Device Recall Curity

  • Model / Serial
    All lots beginning with 110000037462 through Lot 120002259962
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.
  • Product Description
    Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

9 devices with a similar name

Learn more about the data here

  • Model / Serial
    All lots beginning with 110000233562 through lot 120002651262X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.
  • Product Description
    Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) || Item Number: 8047
  • Manufacturer
  • Model / Serial
    All lots beginning with 110000463762 through lot 15K235262
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.
  • Product Description
    Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) || Item Number: 6022
  • Manufacturer
  • Model / Serial
    All lots beginning with 110001358162 through lot 15C033262X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.
  • Product Description
    Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm || Item Number: 6056
  • Manufacturer
  • Model / Serial
    All lots beginning with 110000161662 through lot 15G255462X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.
  • Product Description
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) || Item Number:6522
  • Manufacturer
  • Model / Serial
    All lots beginning with 110000476162 through lot 15J070162X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.
  • Product Description
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) || Item Number:6534
  • Manufacturer
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